Model Number ROB10024 |
Device Problem
Application Program Freezes, Becomes Nonfunctional (4031)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/14/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference: case: (b)(4).
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Event Description
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It was reported that, on calibration of the real intelligence robotic drill in a cori assisted ukr surgery, they received a "robotic drill has been deactivated" error as soon they plugged the connector into the console.They pushed continue to reinitialize the robotic drill and the confirmation green tick on the monitor flickered rapidly and the screen froze.They had to shut the case down and resume the case to continue.The procedure was finished with a smith and nephew back up device with a 5 minute delay.The patient was not harmed.Additionally, after the case, they performed a robotics drill diagnostic test and a robotic drill critical error popped up as soon as they push the start button to initiate the test.When pushing the continue button, a "robotic drill internal error has occured" was displayed.They check the robotic drill and push continue to try again.Also, the ri robotic drill attachment and the real intelligence robotic drill tracker are lock on the drill.
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Manufacturer Narrative
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H3, h6: the real intelligence cori, part number rob10024, serial number (b)(6), intended for use in treatment, was returned for evaluation.The reported problem could not be confirmed with a visual or functional inspection as the console was not returned.A video and pictures of the event were provided and confirm the drill disconnect and flicker.The log files were reviewed and the reported drill disconnect error was confirmed.A relationship between the reported event and the device could not be established.The most likely cause of this event is a faulty exposure motor connection in the drill used for the case.No issues appear to be associated with the cori system itself.A review of manufacturing records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.The failure mode and associated risk have been anticipated within the risk file.The risk level is still adequate.Based on the investigation, the need for a corrective action is not recommended or required at this time.Should any additional information be received the complaint will be reopened.The failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.
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Search Alerts/Recalls
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